Catheter insertion device

ABSTRACT

Embodiments of a catheter insertion device are discussed comprising: an approximately hollow cylindrical catheter sleeve, at whose distal end a catheter is attached; a needle sleeve with a hollow needle, which is attached thereto and which, when ready for use, extends through the catheter sleeve and the catheter, and; a needle protective element that is arranged inside the catheter sleeve while being able to move on the needle. Said needle protective element has an engaging section that engages with an engaging device, which is formed in the vicinity of the needle tip, when the hollow needle is withdrawn from the catheter sleeve. A check valve is placed inside the catheter sleeve between the catheter and the needle protective element. The hollow needle, when ready for use, extends through said check valve, and the check valve automatically closes once the needle is withdrawn.

FIELD

Device, system, and method for a catheter insertion device are generallydiscussed herein with specific reference to catheter device having avalve opener and a valve.

BACKGROUND

A device of this kind is known from EP 352 928, wherein in a hollowcatheter hub a needle guard element is arranged. On withdrawal of thehollow needle from the catheter over an engaging means near the tip ofthe hollow needle, the needle guard element engages with the engagingmeans and covers the tip when the hollow needle is separated from thecatheter. In this design, after withdrawal of the hollow needle from thecatheter, through this catheter blood can issue with which the operatingpersonnel can come into contact.

The invention is based on the object of designing a catheter insertiondevice of the type described above such that an outflow of blood fromthe catheter is prevented after removal of the hollow needle with theneedle guard element.

SUMMARY

This object is solved according to the invention by the features in thecharacterizing part of claim 1. In the ready position, a check valve isarranged in the catheter hub between the catheter and the needle guardelement. Through this valve the hollow needle extends, so that afterwithdrawal of the hollow needle from the catheter the latter can bereliably closed such that an outflow of blood is prevented, whilesimultaneously the tip of the hollow needle is securely covered by theneedle guard element so that the operating personnel cannot injurethemselves on the needle tip.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments of the invention are explained in more detailbelow with reference to the drawing, in which:

FIG. 1 shows a longitudinal section through a catheter insertion devicein the ready position,

FIG. 2 shows the catheter insertion device with the hollow needleremoved,

FIG. 3 shows the device with an attached syringe,

FIG. 4 shows a sectional view along the line A-A in FIG. 1,

FIG. 5 shows a longitudinal section through another embodiment,

FIG. 6 shows a view of the valve disc,

FIGS. 7A, 7B, 7C, 7D, and 7E show different views of a valve actuatingelement,

FIG. 8 shows a longitudinal section through a further embodiment,

FIGS. 9A and 9B show front views of the valve actuating element of FIG.8, and

FIG. 10 shows a longitudinal section through a further embodiment.

DETAILED DESCRIPTION

FIG. 1 shows a catheter insertion device 1 having a catheter hub 2 whichhas a two-part form in the embodiment. A distal hub element 3 of thecatheter hub has a holding section 3 a in which a catheter 4 ispress-fitted. The proximal end of the hub element 3 has an enlargeddiameter with regard to the distal end and forms a connecting sectionwith a hub element 5 whose distal end overlaps the proximal end of thehub element 3 and which is provided at its proximal end with a Luerthread 6. Between the two hub elements 3 and 5, a check valve in theform of a valve disc 7 is inserted and is fixed in place by the two hubelements 3 and 5.

In the ready position according to FIG. 1, there is inserted in thecatheter hub 2 a needle hub 8 to which a hollow needle 9 is fixed whichextends through the valve disc 7 and the catheter 4 so that the needletip 9 a is exposed. Between needle hub 8 and valve disc 7 there isdisplaceably arranged in the proximal hub element 5 a valve actuatingelement 10 which has a truncated cone-shaped locating section 10 a whichserves to open the valve disc 7, as FIG. 3 shows. On the proximal side,a plunger section 10 b adjoins the locating section 10 a and has ahollow space for receiving a needle guard element 13. In the embodimentshown, the plunger section 10 b is formed by two spaced plungers betweenwhich the needle guard element in the form of a spring clip 13 isinserted, as shown in the cross-sectional view in FIG. 4.

On withdrawal of the hollow needle 9 from the catheter hub 2, anengaging means 9 b (FIG. 2), provided near the needle tip 9 a and havingthe form of a radial projection on the hollow needle which can be formedby light crimping, engages with the outer circumference of a bore in therear wall 13 c of the spring clip 13, so that the spring clip 13 isremoved from the catheter hub with the needle 9, while simultaneouslythe spring arms 13 a and 13 b of the spring clip cover the needle tip,completely protecting and blocking it. In this separated position shownin FIG. 2, the valve disc 7, due to its elasticity, closes thethrough-hole for the hollow needle 9 so that no blood can flow outthrough the catheter 4. As FIG. 6 shows, the valve disc is provided forexample with three slits 7 a starting from the middle and extendingradially over a short section X, forming elastic flaps 7 b therebetweenwhich can be expanded by the hollow needle.

FIG. 3 shows the insertion of a syringe 14 in the catheter hub 2,wherein the neck portion 14 a of the syringe comes to abut on theplunger section 10 b of the valve actuating element 10 and presses itagainst the valve disc 7, so that the truncated cone-shaped locatingsection 10 a outwardly displaces the flaps 7 b of the valve disc andthereby opens the valve, so that a liquid can be inserted from thesyringe 14 into the catheter 4.

The incline of the truncated cone on the locating section 10 a and thedisplacement path of the actuating element 10 relative to the valve disc7 are designed such that due to the elasticity of the material of thevalve disc 7, the flaps 7 b displace the locating section 10 a to theright in FIG. 3 when the syringe 14 is removed from the catheter hub 2.Hereby, the valve disc 7 is automatically closed, as the position inFIG. 2 shows.

In the hub element 5, there is formed by a shoulder 5 a a stop for theactuating element 10, to define the position of the actuating element inthe separated position in FIG. 2. Hereby, the truncated cone-shapedlocating section 10 a lies near the stop 5 a, while its distal end abutson the valve disc 7 as shown in FIG. 2. The radial slits 7 a of thevalve disc 7 are designed such that in the ready position in FIG. 1, theflaps 7 b are bent radially upwards less than in the open position bythe locating section 10 a in FIG. 3.

As the cross-sectional view in FIG. 4 shows, the two plungers lob of thevalve actuating element 10 are guided in longitudinal grooves 5 e of thehub element 5 and they project radially inwards into the bore 5 c of thehub element 5, so that they form an abutting surface for the neckportion 14 a of the syringe 14. The bore 5 c in the hub element 5 isformed slightly conically corresponding to the conical neck portion 14 aof a syringe.

On the inner circumference of the bore 5 c of the hub element 5, afurther shoulder 5 b having a smaller diameter is formed, on which theradially outer areas of the spring arms 13 a and 13 b abut in the readyposition in FIG. 1. Hereby, the spring clip 13 is fixed in its positionin the hub element 5. When the needle hub 8 with the hollow needle 9 isremoved from the catheter hub 2, first the spring clip 13 is held on theshoulder 5 b by abutting until the radial projection 9 b comes to abuton the rear wall 13 c of the spring clip. In this position, the twospring arms 13 a, 13 b can be released from the shoulder 5 b and springback inwards to cover the needle tip, as FIG. 2 shows, whereupon thespring clip 13 with the hollow needle 9 can be removed from the catheterhub.

In the embodiment according to FIGS. 1 to 3, the distal end section ofthe hub element 5 is shrunk, welded or bonded onto the proximal endsection of the hub element 3 after the valve actuating element 10 andthe valve disc 7 are inserted in the hub element 5. It is also possibleto join the two hub elements 3 and 5 to one another, for example by athread which is secured against loosening after assembly. The springclip 13 is inserted together with the hollow needle 9 in the bore 5 c ofthe hub element 5 during assembly, wherein the radially outer areas ofthe spring arms 13 a, 13 b snap in at the shoulder 5 b under elasticdeformation.

Preferably, in front of the shoulder 5 b a projection 5 b′ can be formedin the bore 5 c of the hub element, as shown in FIG. 2. Hereby thesnap-in and holding effect of the spring clip 13 is increased.

FIG. 5 shows a modified embodiment of the connection of the two hubelements 3 and 5, in which two cylindrical sections 3 b and 5 d engagein one another. A thread can be provided between these two cylindricalsections. However, it is also possible to bond or weld these twosections.

In this embodiment, the valve actuating element 10 is also modified inrelation to the embodiment of FIGS. 1 to 3. FIG. 7A shows a side view ofthe approximately U-shaped actuating element 10 with the spring clip 13inserted therein. As the side view rotated by 90.degree. in FIG. 7Bshows, the locating section 10 a is partly flattened on opposite sidesso that the width of the plunger sections 10 b extends into the locatingsection 10 a. FIG. 7C is a front view from the left in FIG. 7B and showsthe flattened structure of the locating section 10 a. FIG. 7D is asectional view along the central line in FIG. 7B. FIG. 7E shows asection through the valve actuating element 10 along the line B-B inFIG. 7D.

FIG. 5 shows the lower half of the valve actuating element 10corresponding to the view in FIG. 7A, and the upper half in a sectionalview rotated by 90.degree. corresponding to FIG. 7B. The shoulder 5 afor positioning the valve actuating element 10 in the hub element 5 ishereby formed on the ends of the diametrically opposite grooves 5 e(FIG. 4), so that the proximal ends of the plunger sections 10 b abut onthe shoulders 5 a. Corresponding to the shoulder 5 b in FIGS. 1 to 3 inthe embodiment in FIG. 5, there is formed on the hub element 5 aprojection 5 f which projects inwards at diametrically oppositepositions on the bore 5 c of the hub element 5 and fixes the spring clip13 in the hub element 5 until the spring arms 13 a, 13 b spring inwardsover the needle tip and the spring clip with the hollow needle 9 isremoved from the catheter hub.

FIG. 8 shows a modified embodiment having a hollow cylindrical valveactuating element 10 on whose inner circumference a projection 10 f isformed for positioning the spring clip 13 inside the valve actuatingelement 10. FIG. 9A shows a front view of the valve actuating element 10from the right and FIG. 9B shows a front view from the left in FIG. 8,wherein for locating the neck portion 14 a of a syringe 14, in thisembodiment radially inwardly projecting ribs 10 e are formed whichprotrude radially into the bore 5 c of the hub element 5, as the upperhalf of the valve actuating element in FIG. 8 shows, in which thesectional view of the lower half of the valve actuating element 10 isshown rotated by 90.degree. in relation to the upper half.

FIG. 10 shows a modified embodiment wherein between the two hub elements3 and 5 a check valve 17 is inserted, which has a hollow cylindricalsection 17 b starting from a flange section 17 a and abutting on theinner circumference of the hub element 3. From the inner circumferencenear the flange section 17 a there start two opposite flaps 17 c, whichabut on the outer circumference of the hollow needle 9 in the readyposition in FIG. 10. When the needle 9 is removed from the catheter hub2, the elastically deformed flaps 17 c move inwards and close the valve.In this embodiment, an actuating element for opening the valve 17 is notnecessary, because the pressure of the fluid from the syringe 14displaces the flaps 17 c radially outwards so that the liquid can flowout through the valve 17. In this embodiment of a check valve, aso-called duck-bill valve is concerned, whose construction is in itselfknown.

In FIG. 10, in order to allow the spring clip 13 to be held in thecatheter hub during withdrawal of the hollow needle 9 from the catheterhub 2 until the radial projection 9 b on the hollow needle engages withthe rear wall 13 c to cover the needle tip, in this embodiment there isformed on the inner circumference of the proximal hub element 5 aprojection 5 f which extends radially inwards and on which the radiallyouter areas of the spring arms 13 a and 13 b come to abut and hold thespring clip until the spring arms spring back radially inwards to coverthe needle tip. The inner diameter of the projection 5 f is designedonly slightly smaller than the maximum radial dimension at the springarms 13 a and 13 b, so that during assembly the spring clip 13 can beinserted by slight pressure into the position in the catheter hub asshown in FIG. 10.

In the embodiment of a catheter insertion device according to FIGS. 1 to9, in the position of the valve actuating element 10 in FIG. 2 the valvedisc 7 can be opened by low pressure produced by the syringe 4 fordrawing off liquid from the catheter, wherein the elastic flaps 7 b arebent upward by the low pressure. In the embodiment of FIG. 10, adrawing-off of liquid from the catheter is not possible, because theduck-bill valve does not open when there is low pressure on the proximalside.

It is convenient to fabricate the check valve in the form of a valvedisc 7 or of the flap valve 17 from elastic silicon, while acorrespondingly rigid plastic material is used for the hub elements 3and 5 and for the valve actuating element 10.

What is claimed is:
 1. A catheter insertion device comprising: acatheter hub comprising an interior cavity having an opening at aproximal end; a catheter tube having a distal end opening extendingdistally of the catheter hub; a needle having a needle shaft defining aneedle axis projecting distally of an end of a needle hub, said needleprojecting through the catheter tube and comprising a needle tip; avalve positioned inside the interior cavity of the catheter hub, saidvalve obstructing fluid flow and comprises a slit; said valve remaininginside the interior cavity of the catheter hub when the needle isremoved from the catheter tube and the catheter hub; a valve actuatingelement slidingly disposed in the interior cavity of the catheter hub toactuate the valve in a distal direction, the valve actuating elementcomprising a tapered nose section with an opening structured to push thevalve to open the slit, and at least one plunger element extendingproximally of the nose section and having a cross-sectional dimensionsmaller than the nose section and a proximal end surface; wherein the atleast one plunger element is slidable distally within the catheter hubwhen the proximal end surface is pressed distally to push the valve toopen the slit; and a needle protective device positioned proximal of thevalve and at least in part around the needle and distal of the proximalend of the needle hub in a ready position, the needle protective deviceis movable to prevent unintended needle sticks.
 2. The catheterinsertion device of claim 1, wherein the valve comprises three slitsthat converge at a single point.
 3. The catheter insertion device ofclaim 1, wherein the catheter hub is made from two hub housing sectionsattached to one another.
 4. The catheter insertion device of claim 1,wherein the valve has a radial outer perimeter abutting the interiorcavity of the catheter hub.
 5. The catheter insertion device of claim 1,further comprising a second plunger element spaced from the at least oneplunger element.
 6. The catheter insertion device of claim 5, whereinthe needle projects between the second plunger element and the at leastone plunger element in the ready position.
 7. The catheter insertiondevice of claim 1, wherein the valve actuating element further comprisesa projection located proximally of the tapered nose section and projectsradially outwardly of the nose section and abutting a shoulder of thecatheter hub.
 8. The catheter insertion device of claim 1, wherein theneedle protective device comprises an arm that is located, at least inpart, in the catheter hub.
 9. The catheter insertion of claim 1, furthercomprising a crimp on the needle near the needle tip.
 10. The catheterinsertion device of claim 1, wherein the catheter hub further comprisesa shoulder in the interior cavity of the catheter hub, the shoulderbeing a stop for the valve actuating element.
 11. A catheter insertiondevice comprising: a catheter hub comprising an interior cavity, anopening at a proximal end, and a catheter tube attached to a distal end;a needle having a needle shaft defining a needle axis projectingdistally of an end of a needle hub, said needle projecting through thecatheter tube in a ready position and comprises a needle tip; a valvepositioned inside the interior cavity of the catheter hub and in contactwith the interior cavity, said valve being sized and shaped to obstructfluid flow and comprises a wall surface comprising a slit; said valveremaining inside the interior cavity when the needle is removed from thecatheter tube and the catheter hub; a valve actuating element slidinglydisposed in the catheter hub to actuate the valve, the valve actuatingelement comprising a nose section having a tapered end for pushing thevalve to open the slit and a plunger end extending proximally of thenose section; the plunger end transferring a distally directed force tothe nose section to push the valve to open the slit when pressed upon;and a needle protective device spaced from the needle tip in the readyposition and movable relative to the needle tip, at least in partdistally of the needle tip to prevent unintended needle sticks.
 12. Thecatheter insertion of claim 11, wherein the plunger end comprises atleast two spaced apart plunger elements.
 13. The catheter insertiondevice of claim 11, wherein the needle comprises a crimp on the needlenear the needle tip.
 14. The catheter insertion device of claim 11,wherein the valve comprises three slits that converge at a single point.15. The catheter insertion device of claim 11, wherein the needleprotective device comprises a proximal wall and two arms that convergeat a single point when viewed along a side of the needle.
 16. Thecatheter insertion device of claim 11, wherein the catheter hub is madefrom two hub housing sections that are attached to one another.
 17. Thecatheter insertion device of claim 11, wherein the valve actuatingelement further comprises a projection located proximally of the taperednose section and projects radially outwardly of the nose section andabutting a shoulder of the catheter hub.
 18. The catheter insertiondevice of claim 17, wherein the projection is distal of the at least twoplunger elements.
 19. The catheter insertion device of claim 11, whereinthe needle protective device comprises an arm that is located, at leastin part, in the catheter hub.
 20. The catheter insertion device of claim11, wherein the catheter hub further comprises a shoulder in theinterior cavity of the catheter hub, the shoulder being a stop for thevalve actuating element.